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Elizabeth Dudnik



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    P21 - Locoregional and Oligometastatic Disease - Treatment of Locally Advanced NSCLC (ID 131)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Locoregional and Oligometastatic Disease
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P21.11 - Durvalumab after Concurrent cChemotherapy and High-Dose Radiotherapy in Locally Advanced Non-Small Cell Lung Cancer (ID 2181)

      00:00 - 00:00  |  Author(s): Elizabeth Dudnik

      • Abstract
      • Slides

      Introduction

      Since the publication of the PACIFIC trial, the current standard of care for patients with locally advanced non-small cell lung cancer (LANSCLC) is chemoradiotherapy (CRT) followed by durvalumab. The optimal radiation dose for LANSCLC is controversial. In our center, doses higher than 66 gray are standard but such doses were used in only 49 (6.9%) of randomized patients in the PACIFIC trial. Here we report our real-world experience with durvalumab after high dose CRT.

      Methods

      All consecutive patients with LANSCLC treated with durvalumab after CRT in 2018-2019 were identified through pharmacy database. Approval for the study was given by the Helsinki committee. Progression-free survival (PFS) and overall survival (OS) were measured from durvalumab first administration. Patients' characteristics, dosimetric parameters, and toxicities were extracted from electronic medical records. Statistical analysis was performed using Mann-Whitney U-tests and Kaplan-Meier method.

      Results

      A total of 31 LANSCLC patients treated with durvalumab after CRT were identified. All were treated with intensity-modulated radiotherapy, with mean radiation dose of 70.4 gray. 1/31(3.2%) patient was treated with radiation only due to co-morbidities. Median follow-up was 13.1 months [range 2-24.1]. At 12 months, PFS, OS and local failure rates were 58.1%, 83.9% and 12.9%, respectively. Median PFS and OS were not reached. The most common toxicity was fatigue, occurring in 27/31(87.1%) patients. Treatment-related adverse events requiring corticosteroids occurred in 7/31(22.6%) patients; 2/31(6.5%) with hepatitis and 5/31(16.1%) with pneumonitis. One (3.2%) patient died due to pneumonitis. Occurrence of treatment-related pneumonitis was significantly associated with higher Lung V5, V20 and mean lung dose values (57.3% vs. 49.4%, p=0.04, 31% vs. 24.5%, p=0.048, 19.2 Gy vs.15.1 Gy, p=0.043, respectively).

      Conclusion

      The 12-months PFS and OS rates in this cohort were comparable to the PACIFIC results. This confirms the results in real-life population treated with high-dose radiotherapy. No new toxicity signals were found, and treatment-related mortality was similar to PACIFIC results. Treatment-related pneumonitis was as expected correlated to radiation dose metrics but was not increased with high dose radiotherapy.

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    P50 - Small Cell Lung Cancer/NET - Real World Outcomes (ID 232)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P50.04 - Real-World Survival Outcomes with Immune Checkpoint Inhibitors in Large Cell Neuroendocrine Tumors of Lung. (ID 1949)

      00:00 - 00:00  |  Presenting Author(s): Elizabeth Dudnik

      • Abstract
      • Slides

      Introduction

      While immune checkpoint inhibitors (ICI) have emerged as standard of care for most patients with advanced lung cancer, little is known regarding their efficacy in patients with advanced large cell neuroendocrine tumors of lung (aLCNEC). We sought to report real-world outcomes in this population.

      Methods

      125 consecutive patients with aLCNET were identified in the electronic databases of 4 participating cancer centers. Tumors were classified as small-cell lung cancer (SCLC)-like (TP53+RB1 co-mutations or loss), non-small-cell lung cancer (NSCLC)-like (lack of TP53/RB1 alterations), or molecular subtype unknown. Overall survival (OS) since advanced disease diagnosis (OS DX) and OS since ICI initiation (OS ICI) were captured.

      Results

      Among 125 patients with aLCNEC, 7 were SCLC-like, 15 were NSCLC-like and 103 were unknown; 41 patients received ICI (Group A) and 84 did not receive ICI (Group B). With median follow-up of 11.8 months (mo) [IQR, 7.5-17.9] and 6.0 mo [IQR, 3.1-10.9], 66% and 76% of patients died in groups A and B, respectively. Median OS DX was 12.4 mo (95% CI, 10.7-23.4) and 6.0 mo (95% CI, 4.7-9.4) in groups A and B, respectively (p-0.02) (Figure A). HR for OS DX was 0.59 (95% CI, 0.38-0.93 - unadjusted) and 0.55 (95% CI, 0.33-0.92 - adjusted for age, ECOG PS and presence of liver metastases) (Figure B). OS ICI for patients receiving ICI as monotherapy (n=36) was 11.0 mo (6.1-19.4). In the univariate analysis, ECOG PS at ICI initiation (ECOG PS 0/1 vs 2-4; HR-0.38; 95% CI, 0.15-0.95) and presence of liver metastases (HR-3.04; 95% CI, 1.33-6.96) significantly correlated with OS ICI. Patients with NSCLC-like aLCNEC had numerically worse outcomes with ICI (Table).

      Table.

      Group

      OS DX

      median (95% CI), mo

      p value

      HR (adjusted for age, ECOG PS, liver metastases)

      (95% CI)

      OS ICI

      median (95% CI), mo

      A (ICI, n=41)

      12.4 (10.7-23.4)

      0.02

      0.55 (0.33-0.92)

      B (no ICI, n=84)

      6.0 (4.7-9.4)

      A (ICI, NSCLC-like, n=10)

      11.6 (10.6-NR)

      0.63

      B (no ICI, NSCLC-like, n=5)

      18.6 (16.9-NR)

      A (ICI as monotherapy, n=36)

      11.0 (6.1-19.4)

      A (ICI as monotherapy, NSCLC-like, n=9)

      9.3 (6.1-NR)

      Figure.

      figure.gif

      Conclusion

      In aLCNEC, ICI had a positive impact on OS. Prospective research is needed to validate these results and to correlate the benefit with the tumor molecular subtype.

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    P84 - Targeted Therapy - Clinically Focused - ALK (ID 261)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Targeted Therapy - Clinically Focused
    • Presentations: 2
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P84.03 - GLASS: Global Lorlatinib for ALK(+) and ROS1(+) Retrospective Study: Real World Data of 123 NSCLC Patients (ID 3172)

      00:00 - 00:00  |  Author(s): Elizabeth Dudnik

      • Abstract
      • Slides

      Introduction

      Lorlatinib is a third-generation tyrosine-kinases inhibitor (TKI) targeting ALK/ROS1 fusions. The FDA has approved lorlatinib for TKI-pretreated ALK(+) NSCLC, while its approval for ROS1(+) is still pending. Here we present the largest real-world data of NSCLC patients harboring ALK/ROS1 rearrangements treated with lorlatinib.

      Methods

      This is an international, multicenter, retrospective study, which aimed to describe the efficacy and safety of lorlatinib in previously treated ALK/ROS1(+) NSCLC. All patients were treated through an early access program, when no other targeted therapy was available.123 patients were enrolled retrospectively (data cut-off 1/1/2019). Outcome and response were defined by each investigator upon RECIST 1.1 criteria.

      Results

      From March 2015 to January 2019, 106 ALK(+) and 17 ROS1(+) patients were recruited from 8 different countries. The ALK(+) cohort included 50% males, 73% never-smokers and 68% with brain metastases. Extracranial (EC) and intracranial (IC) response rates (RR) were 60% and 62%, with disease control rates (DCR) of 91% and 88% respectively. Mean duration of therapy (DoT) was 23.9±1.6 months and median overall survival (mOS) was 89.1±19.6 months. ROS1 cohort enrolled 53% males, 65% never-smokers and 65% had brain metastases. EC and IC RR were 62% and 67% with DCR of 92% and 78% respectively. Median DoT was 18.1±2.5 months and mOS of 90.3±24.4 months. OS and DoT in both cohorts were not significantly correlated with line of therapy nor other parameters.

      The most common adverse events of any grade were peripheral edema (48%), hyperlipidemia (47%), weight gain (25%) and fatigue (30%). CNS adverse events such as cognitive effect of grade 1-2 were reported in 18% of patients.

      Conclusion

      Lorlatinib shows outstanding extracranial and intracranial efficacy in ALK or ROS1(+) NSCLC. The observed mOS of 89±19 months in ALK(+) NSCLC supports previous reports, while mOS from of 90±24 months is unprecedented for ROS1(+) NSCLC.

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      P84.10 - The Impact of 3rd-Line ALK Inhibitors in ALK Positive NSCLC in Real-World Data (ID 3662)

      00:00 - 00:00  |  Author(s): Elizabeth Dudnik

      • Abstract
      • Slides

      Introduction

      ALK inhibitors (ALKi) are the standard treatment for metastatic ALK-rearranged Non-Small Cell Lung Cancer (NSCLC) patients in the first and second line setting. We conducted a real-world multi-institutional study, aiming to compare third-line ALKi versus chemotherapy in these patients.

      Methods

      Consecutive ALK-positive advanced NSCLC patients, treated with at least one ALKi were identified in the working databases of seven Israeli oncology centers (the full cohort). Demographic and clinical data was collected. Patients receiving any systemic treatment beyond 2 ALKi comprised the third-line cohort, whether a third ALKi (Group A) or chemotherapy (Group B). Groups were compared in terms of overall survival (OS) and time-to-next-treatment line (TNT).

      Results

      For the full cohort (n=170), with a median follow up of 41 months, median OS (mOS) was 52 months (95% CI: 32-65). Age (HR 1.02, 95% CI: 1.01-1.04, p=0.009) and the number of ALKi (HR 0.765; 95% CI: 0.61-0.95; P=0.024) were significantly correlated with OS. The third-line cohort included 40 patients; 27 - group A, 13 - group B. The mOS of the third-line cohort from the onset of third line was 27 months in group A (95% CI: 13-NR), and 13 months for group B (95% CI: 3-NR; p=0.12). Chemotherapy as first line (HR 0.17, 95% CI: 0.05-0.52, p=0.002) and a higher number of ALKi (HR 0.38, 95%CI: 0.20-0.86, p=0.011) correlated significantly with OS of the third-line cohort. TNT was 9 months for group A (95% CI: 5-19) and 3 months for group B (95% CI: 0-NR, p=0.085).

      Conclusion

      We report mature real-world data of more than 4 year median OS in ALK-positive patients. First-line chemotherapy for these patients was associated with better outcome, suggesting further studies are required of such an approach. OS and TNT demonstrated a statistically non-significant trend for better outcome in patients receiving a third-line ALKi.

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